Specification Test Results

• Assay (calc. on dried substance):
  99.0- 101 .0 %
• Assay (calc. as dihydrate):
  99.0- 101.0 %
• Identification (IR):
  Complies
• ldentity complexation (edetate):
  Complies
• ldentity of sodium:
  Complies
• Appearance:
  White to almost white, crystalline powder
• Appearance of solution (5%, water):
  Clear and colorless
• pH (1%, water):
  4.3-4.7
• pH (5%, water):
  4.0- 5.5
• Cyanide (CN):
  Not more than 1 ppm
• Heavy metals (as Pb):
  Not more than 10 ppm
• Arsenic (As):
  Not more than 1 ppm
• Iron (Fe):
  Not more than 5 ppm
• Calcium (Ca):
  Complies
• Nitrilotriacetic acid:
  Not more than 0.1 %
• Methanol (GC):
  Not more than 3000 ppm
• Loss on drying:
  8. 7 - 11.4 %
• Sulphated ash:
  37.0- 39.0 %
• Other residual solvents (ICH Q3C):
  Excluded by production process